Designing Clinical Research : An Epidemiological Approach

Any one who has ever conducted any form of clinical research is aware of that eternal quest for the ‘holy grail’ of biomedical research-the elusive ‘p value’. Mostly medical education is silent on the issues of research methodology especially in the clinical fields, with masterful inactivity being the preferred mode, allowing students the latitude to chart their own course through the minefields of clinical research. The book reviewed here is a practical guide to planning, tabulating, formulating and implementing clinical research. It is a ‘no frills’, straightforward and reader friendly book. The structured approach by the authors to the issue of clinical research viewed from a clinicians perspective, with the viewpoint of a statistician has resulted in a balanced treatment of the subject, without overly emphasizing the statistical part, which most clinicians usually find unpalatable. The book provides physicians and clinical investigators rigorous and complete descriptions of key components while emphasizing common sense as the main ingredient of good science. The easy to read uncomplicated presentation is highlighted by the logical flow of the chapters. The development of the research question is emphasized and as is popular with Research Methodologists, the fundamental issue that needs to be investigated is framed in suitable terms, to guide the novice intiate. Our advice to readers would be to read through all the chapters in the sequence laid out, to enable a broader grasp of the subject and insight into the mechanics of study design. The authors of the book conduct summer workshops on research design for budding researchers regularly, and the text is based on their experiences, in introducing the subject to lay medical professionals. The chapters are liberally peppered with realistic examples with a summary at the end of each, to serve as a ‘take home message’. The inclusion of exercises literally exercises one's learning of the subject content through posing of practical questions in relevant situations. An interesting feature is the ‘Common Errors to Avoid’ section, which invariably are the errors that would be committed otherwise. The chapter on designing studies for evaluation of medical tests serves as an introduction to the tricky issue that confronts many practitioners faced with the proliferation of diagnostic tests in the marketplace. The well written overview serves as a teaser to the topic. The ethical concerns that are emerging in the research field all over the world are addressed adequately. The importance of designing questionnaires and data collection instruments scientifically is dwelt upon at length and should serve as a pointer to researchers who may not consider this important enough at the design stage. However the authors could have given more illustrative examples of the various questionnaires to make the experience more practical for the reader. With the opening up of the availability and access to research funding and grants from the Western world, the chapter on writing proposals would be relevant to researchers from India in providing a take off point, though specific issues in grant application writing would need to be gleaned from the websites of the various funding agencies. The book is recommended primarily for clinicians intent on embarking on clinical research, however it is not intended to be a ‘Do-it-Yourself’ manual, with the need for teamwork and cooperation between epidemiologists, bio statisticians and clinicians being the sine qua non for a successful research project. Post graduate students from all specialities will benefit from this introductory text and hence libraries may consider this an essential addition to their collection.